Clinical Research Directory

A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors

This study is to evaluate the safety and tolerability to determine (i) the recommended Phase 2 dose (RP2D) of VMD-102 (Phase 1), and (ii) preliminary anti-tumor efficacy (Phase 2), in participants with advanced HCC, metastatic uveal melanoma (MUM), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). The pharmacokinetics (PK), preliminary anti-tumor activity, and potential biomarkers of VMD-102 will also be assessed. VMD-102 will be the first selective PKC epsilon (PKCε or PKCe) kinase inhibitor to enter human clinical testing. Preclinical VMD-102 anti-tumor activities in mouse liver/HCC tumor models and preclinical toxicology and pharmacology studies support this study.

A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies

The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are: * What is the safe dose of KQB368 as a monotherapy? * Does KQB368 decrease the size of the tumor? * What happens to KQB368 in the body? Participants will: * Take KQB368 orally daily in 21-day cycles * Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SYS6062 in Patients With Advanced Solid Tumors.

This study is a multicenter, open-label, dose-escalation, PK expansion, and cohort expansion, first-in-human phase I/II study to evaluate the safety, tolerability, PK profile, and preliminary antitumor efficacy of SYS6062, a CEACAM5-targeted antibody-conjugate drug, in patients with advanced solid tumors.

Toripalimab Plus Cetuximab and Irinotecan for Second-Line Right-Sided RAS/BRAF Wild-Type Advanced Colon Cancer Phase II Study

This phase II, single-arm clinical study aims to evaluate the efficacy and safety of toripalimab combined with cetuximab and irinotecan as second-line treatment for patients with advanced right-sided colon cancer with wild-type RAS and BRAF genes. The study will enroll up to 46 adult patients with recurrent or metastatic right-sided colon cancer whose disease has progressed after first-line systemic therapy. Eligible patients must have wild-type RAS and BRAF genes and must not have previously received anti-EGFR antibodies or irinotecan. All participants will receive toripalimab, cetuximab, and irinotecan by intravenous infusion every two weeks. Treatment will continue until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation. The primary outcome is the objective response rate (ORR), assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary outcomes include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and treatment safety. Exploratory analyses will investigate potential biomarkers associated with treatment response using blood, tumor tissue, and other biological samples. This study seeks to generate clinical evidence regarding the potential efficacy and safety of this combination therapy in patients with advanced right-sided colon cancer who require second-line treatment.

Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer

This is a prospective, open-label, randomized, parallel-group phase II trial evaluating the efficacy and safety of a low-dose radiotherapy sensitization strategy combined with a PD-1 antibody (pucotenlimab) and CAPEOX as neoadjuvant therapy in patients with pMMR/MSS locally advanced rectal adenocarcinoma. Participants will be randomized 1:1 to receive either 2 Gy or 5 Gy low-dose radiotherapy. Low-dose radiotherapy is delivered as a single fraction of 2 Gy (Arm A) or 5 Gy (Arm B). On the day after radiotherapy, participants will start pucotenlimab 200 mg IV Q3W (administered on Day 2 of each 21-day cycle) plus CAPEOX chemotherapy. Tumor response will be assessed after two cycles using endoscopy and pelvic magnetic resonance imaging (MRI). Participants with non-progressive disease, defined as partial response (PR) or stable disease (SD), will receive no further low-dose radiotherapy and will continue pucotenlimab plus CAPEOX for cycles 3 and 4. Participants with local progressive disease, defined as enlargement of the rectal tumor, will receive salvage chemoradiotherapy according to the center's standard operating procedures. Participants who develop distant metastases will receive further treatment determined by a multidisciplinary team (MDT). After four cycles, participants who achieve a clinical complete response (cCR) may enter a watch-and-wait strategy. Participants without cCR and without progressive disease will undergo radical surgery according to total mesorectal excision (TME) principles. Participants with progressive disease will receive individualized treatment determined by the MDT.

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyltransferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.

Relative Bioavailability/Bioequivalence of Different Formulations of Selinexor, the Impact of Hepatic Impairment on Selinexor Pharmacokinetics, Tolerability and Antitumor Activity of Selinexor Combination Treatment

This is a Phase 1/2, two-part, multi-arm, open-label study in patients with normal Hepatic Function (HF), with either Non-small cell lung cancer (NSCLC), who have had 1-2 prior lines of treatment, with 1 line containing a checkpoint Inhibitor (CPI); or patients with normal HF, with colorectal cancer (CRC) who have had 1-3 prior lines (KRAS wild-type \[WT\]) or 1-2 prior lines (mutant KRAS) of treatment with no CPI; or patients with impaired HF, with any solid tumor, who have had at least 1 prior line of treatment. The study will comprise 2 treatment periods (monotherapy and combination therapy). The purposes of this study, during Monotherapy period, are: (1) to determine the relative bioavailability of the 100 milligrams (mg) (Tablet B) and 20 mg (Tablet A) tablets of selinexor at 100 mg once weekly (QW) dose in patients with normal hepatic function; and (2) to assess the PK of selinexor after a single dose of 40 mg (2 × 20 mg), among patients with moderate and severe hepatic impairment, relative to 100 mg (5 × 20 mg), among patients with normal hepatic function; and, during the Combination therapy period, to assess the preliminary anti-tumor activity of selinexor in combination with docetaxel in patients with NSCLC and with pembrolizumab or folinic acid, 5-fluorouracil, and irinotecan (FOLFIRI) in patients with CRC.

TIVA Versus Balanced Anesthesia on Muscle Mass in CRC Surgery

This study is aimed at clarifying changes in body composition during the perioperative period and identifying risk factors for skeletal muscle mass loss in patients with colorectal cancer. The investigators will asess the impact of the type of anaesthesia (total intravenous anaesthesia/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass, which will be evaluated using ultrasound, dynamometry and bioimpedance.

Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors

This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) and in combination with docetaxel and prednisone in participants with advanced solid tumors. In addition, the study will evaluate the effect of multiple dose administration of zanzalintinib on the single-dose pharmacokinetics of sensitive CYP3A4, CYP2C9, CYP2C19, or CYP1A2 substrates in participants with advanced solid tumors. In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.

Reduce Sedentary Behavior During Cancer Treatment - the RedSedCan Study

Summary Reducing sedentary behavior during treatment is important to reduce the risk of future health problems in individuals undergoing cancer treatment. Therefore, the goal of this project is with a multicenter randomised controlled design investigate whether a digital support intervention during ongoing neo- or adjuvant cancer treatment for breast, prostate or colon cancer is effective in reducing sedentary lifestyle and improving well-being in the short and long term.

A Prospective Real-World Observational Study of Intratumoral Oncolytic Virus Injection Combined With Immune Checkpoint Inhibitors for Metastatic Tumors (Colorectal Cancer, Gastric Cancer, and Hepatocellular Carcinoma)

The goal of this single-arm, open-label, prospective clinical trial is to evaluate the safety, feasibility, and preliminary antitumor activity of intratumoral oncolytic virus (H101, recombinant human type 5 adenovirus) combined with immune checkpoint inhibitors (ICIs), and to explore the dynamic remodeling of the tumor immune microenvironment and potential predictive biomarkers, in patients with advanced metastatic colorectal cancer, gastric cancer, or hepatocellular carcinoma who have failed multiple prior lines of therapy. The main questions it aims to answer are: What are the incidence of treatment-related adverse events and serious adverse events, and the completion rate of the combination therapy (safety and feasibility)? What is the objective response rate and local control rate per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (preliminary antitumor activity)? How does the combination therapy reshape the tumor immune microenvironment in terms of immune cell infiltration, subset proportions, functional status, and signaling pathways, and which differentially expressed genes or immune cell subtypes are associated with clinical response? This is a single-arm study; there is no comparator group. Participants will: Receive intratumoral H101 injection once per cycle (dose stratified by lesion size), followed 5-7 days later by intravenous ICI \[Anti-Programmed Cell Death Protein 1 Antibody (anti-PD-1) with or without Anti-Cytotoxic T-Lymphocyte-Associated Protein 4 Antibody (anti-CTLA-4)\], repeated every 2-3 weeks for a total of 4 cycles. Provide paired tumor biopsy samples and peripheral blood specimens at baseline and after 4 cycles for single-cell RNA sequencing and biomarker analyses. Undergo routine clinical assessments, imaging for tumor response evaluation, and safety monitoring with adverse event grading per Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).

Liquid Biopsy Biomarkers for Endoscopic Surveillance in Lynch Syndrome

Lynch syndrome (LS) is an autosomal dominant hereditary condition that markedly increases the risk of colorectal cancer (CRC) and other malignancies. Standard surveillance relies on colonoscopy every 1-2 years starting at age 20-25 years, an invasive and costly procedure that may become burdensome during lifelong follow-up and may miss interval cancers. This prospective, single-institution, observational study aims to identify minimally invasive plasma, stool, and urine biomarkers that could improve the detection of early colorectal lesions in individuals with LS and help refine surveillance protocols. Biomarker analyses include microsatellite instability (MSI) and MMR-related frameshift mutations in circulating tumor DNA, plasma and stool microRNA profiling, stool microbiome analysis, and exploratory urine cell-free DNA banking. Patients with genetically confirmed LS followed at Fondazione IRCCS Istituto Nazionale dei Tumori will be enrolled and followed for 24 months, undergoing surveillance colonoscopy at baseline, 12 months, and 24 months, with periodic venous blood sampling and stool, urine, and tissue collection according to protocol.

Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors.

Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.

A Study of JZP815 Oral Capsules in Adult Participants With Advanced or Metastatic Solid Tumors Harboring Mitogen Activated Protein Kinase (MAPK) Pathway Alterations to Investigate the Safety, Dosing, and Antitumor Activity of JZP815

This phase 1 study will investigate the safety, dosing, and initial antitumor activity of JZP815 in participants with advanced or metastatic solid tumors harboring alterations in the MAPK pathway.

SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors

This Phase 1, open-label study will evaluate two investigational radiopharmaceuticals in adults with selected advanced or metastatic solid tumors. SKL35502 is an imaging agent used with SPECT scans to identify tumors with neurotensin receptor 1 (NTSR1), a protein found on some cancer cells, and to assess where the agent travels in the body and the radiation dose delivered to tissues. Participants with sufficient SKL35502 tumor uptake may receive SKL35501, a treatment designed to deliver targeted alpha radiation to NTSR1-expressing tumor cells. Part A will evaluate the safety and imaging performance of SKL35502 and the safety, tolerability, pharmacokinetics, biodistribution, dosimetry, and biologically active dose range of SKL35501, as well as preliminary antitumor activity. Part B will further evaluate selected SKL35501 dose levels, including randomized low- and high-dose groups in participants with colorectal cancer, and will expand evaluation in selected tumor types. The study will also examine relationships among SKL35502 imaging, NTSR1 expression, SKL35501 tumor uptake, and treatment outcomes.

Mindfulness and Self-Compassion Intervention for Ostomy Patients Due to Colorectal Cancer on Loneliness (MSC-OP)

Loneliness is a profound health risk for colorectal cancer (CRC) survivors, particularly those with stomas who face significant stigma and social anxiety. According to the hypervigilance model, individuals with loneliness often internalize negative stereotypes and anticipate social rejection, leading to chronic isolation and perceived social isolation. Mindful Self Compassion (MSC) offers a potential solution by targeting the psychological mechanisms of shame and self-criticism. By activating the emotional "soothing system" and fostering a sense of common humanity, self-compassion can buffer the impact of stigma and reduce social fear. Despite its promise, the application of MSC within the oncology-ostomy context has rarely been tested. This randomized controlled pilot trial aims to evaluate the feasibility and preliminary efficacy of an adapted MSC for ostomy patients (MSC-OP) program due to CRC in alleviating loneliness, stigma, and social anxiety through improving self-compassion among CRC patients with ostomy. The findings will determine the suitability of Mindful Self-compassion as a targeted intervention to improve the psychosocial outcomes and social reintegration of this vulnerable population.

Raising Awareness of Colorectal Screening in American Indian Communities

This study focuses exclusively on American Indian individuals within their communities to enhance health equity and address a critical tribal health priority. American Indian populations experience some of the highest colorectal cancer (CRC) mortality rates in the nation. By conducting research within these communities, this study aims to improve early detection, prevention, and treatment strategies tailored to their specific needs. The findings will help develop targeted interventions to reduce CRC disparities and improve health outcomes for American Indian individuals.

Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors

The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of \[68Ga\]Ga-DFC413, and in Part 2 compare to \[68Ga\]Ga-NNS309 in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC), colorectal cancer (CRC), and soft tissue sarcoma (STS). In Part 2 of this study (comparison of \[68Ga\]Ga-DFC413 and \[68Ga\]Ga-NNS309), not all indications might be explored.

Trends and Short-term Outcomes of Surgically Resected Early-onset Colorectal Cancer in Switzerland Between 2003 and 2022

The incidence of early-onset colorectal cancer (EOCRC; patients younger than 50 years) has increased worldwide over recent decades. This study aimed to provide nationwide evidence on surgically treated EOCRC in Switzerland.

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer

This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal Cancer

An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib

The purpose of this study is to provide continued supply of ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone to subjects from an Incyte-sponsored study of ruxolitinib that has reached its study objectives or has been terminated. This study will also provide another mechanism for reporting adverse events related to study drug safety.

Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients

The goal of this clinical trial is to clarify the efficacy and safety of transcutaneous electrical acustimulation (TEA) in elderly patients with colorectal cancer, and to evaluate its clinical value in promoting postoperative intestinal function recovery and reducing the incidence of intestinal complications. The main questions it aims to answer are: Can TEA promote the recovery of intestinal function in elderly patients with colon cancer after surgery? What medical problems might occur to the participants when using TEA? The researchers will compare TEA with the control group (non-acupoint sham stimulation) to see if TEA is effective in promoting the recovery of intestinal function after surgery. Participants will: Starting from the first day after the surgery, they received TEA or sham stimulation twice a day for a total of 3 days. Record the time of the first defecation, defecation, and eating. Record their symptoms and adverse events.

A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of \[68Ga\]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC); Part B: is to determine the recommended phase 2 dose (RP2D) \[maximum tolerated dose (MTD) or lower dose\] for \[177Lu\]Lu-DPI-4452 for each tumor type such as ccRCC, PDAC, CRC, and urothelial carcinoma (UC); Part C: is to evaluate the preliminary antitumor activity of \[177Lu\]Lu-DPI-4452 as monotherapy for each tumor type such as ccRCC, PDAC, CRC, and UC; Part D: is to assess the diagnostic concordance between \[68Ga\]Ga-DPI-4452 Positron Emission Tomography (PET) and the histopathology result of the Indeterminate Renal Mass (IDRM); Part E: is to assess \[68Ga\]Ga-DPI-4452 uptake in each tumour type such as UC, muscle invasive bladder cancer (MIBC), head and neck cancer (H\&N), triple negative breast cancer (TNBC), squamous non-small cell lung cancer (NSCLC), and any other tumor with locally confirmed carbonic anhydrase (CA) IX expression except ccRCC, CRC and PDAC.